Core Insights - Oculis Holding AG has advanced its candidate Privosegtor into a registrational program for neuro-ophthalmology indications following a positive meeting with the FDA, marking a significant milestone for the company [2][3][7] - The PIONEER Program will include multiple global trials aimed at supporting registrations for Privosegtor in Acute Optic Neuritis (AON) and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) [1][3][5] Company Overview - Oculis is a global biopharmaceutical company focused on innovations addressing neuro-ophthalmic diseases with significant unmet medical needs [2][16] - The company is led by an experienced management team and supported by international healthcare investors [16] Product Development - Privosegtor is a novel peptoid small molecule candidate that has the potential to be the first neuroprotective therapy for AON and NAION [3][12] - The PIONEER program will consist of three pivotal trials: PIONEER-1 and PIONEER-2 for AON, and PIONEER-3 for NAION, with the first trial expected to start in Q4 2025 [4][5][8] Clinical Trials - PIONEER-1 and PIONEER-2 will evaluate Privosegtor in patients with AON, measuring low-contrast visual acuity at 3 months as the primary endpoint [4][5] - PIONEER-3 will evaluate Privosegtor after the acute onset of NAION, sharing core design elements with the other two trials [5] Market Potential - AON and NAION are rare neuro-ophthalmic diseases with high unmet medical needs for therapies that can provide neuroprotection and preserve vision [6][15] - The CEO of Oculis highlighted that the PIONEER program positions the company as a leader in ophthalmic neuroprotection drug development, targeting multi-billion-dollar markets [7][12] Financial Position - As of September 30, 2025, Oculis reported approximately $182 million in cash, cash equivalents, and short-term investments, with a cash runway expected into the second half of 2027 [9]

Core Viewpoint - Immunic, Inc. is actively participating in several scientific and investor conferences in October 2025 to present data on its clinical pipeline, particularly focusing on its orally administered therapies for chronic inflammatory and autoimmune diseases [1][2][3]. Conference Participation - Immunic's R&D team will present data on IMU-856 at the United European Gastroenterology Week (UEGW) in Berlin, Germany, from October 4-7, 2025, highlighting its positive effects on gut hormone levels in celiac disease patients [2]. - At the 17th International Congress of the International Society of Neuroimmunology (ISNI) in Chiba, Japan, from October 5-8, 2025, Immunic will present data on its lead asset, vidofludimus calcium (IMU-838), which exhibits signs of neuroprotection in preclinical models [2][3]. - Immunic's CEO and CFO will participate in the Roth's 4th Annual Healthcare Opportunities Conference in New York on October 9, 2025, discussing the next wave of innovation in underserved indications [2]. - A virtual fireside chat with Immunic's leadership will take place on October 23, 2025, as part of H.C. Wainwright's HCW @ Home event [2]. Clinical Development Programs - Vidofludimus calcium (IMU-838) is currently in phase 3 clinical trials for relapsing multiple sclerosis, with top-line data expected by the end of 2026. It has shown therapeutic activity in phase 2 trials for both relapsing-remitting and progressive multiple sclerosis [3]. - IMU-856 targets SIRT6 to restore intestinal barrier function and may be applicable in various gastrointestinal diseases, including celiac disease and inflammatory bowel disease [3]. - IMU-381, currently in preclinical testing, is a next-generation molecule aimed at addressing gastrointestinal disease needs [3].

ZUG, Switzerland, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Privosegtor ACUITY Trial showed Improved LCVA and preservation of Ganglion Cells in Acute Optic Neuritis. Results from a Multicenter Randomized Placebo-Controlled Double-Masked Trial Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (“Oculis”), a global biopharmaceutical company focused on innovations for ophthalmic and neuro-ophthalmic diseases with significant unmet medical needs, today announced the upcoming presentation of the positive Phase 2 ACUITY tria ...

Core Insights - Oculis Holding AG has appointed Mark Kupersmith, M.D. as Chief Medical Advisor for Neuro-Ophthalmology and Sebastian Wolf, M.D., Ph.D. as Chief Medical Advisor for Ophthalmology, enhancing its leadership team to drive advancements in ophthalmic and neuro-ophthalmic diseases [1][5][6] Company Developments - Oculis has made significant progress in its clinical pipeline, completing enrollment in Phase 3 DIAMOND trials for OCS-01 targeting diabetic macular edema and aligning with the U.S. FDA on a genotype-based development program for Licaminlimab (OCS-02) in dry eye disease [2][4] - Positive topline results were announced for Privosegtor (OCS-05) in acute optic neuritis, marking a pivotal step towards new therapies for neuronal and axonal preservation [2][4] Leadership Expertise - Mark Kupersmith, M.D. brings over 40 years of experience in neuro-ophthalmology, with a focus on acute optic nerve disorders and significant contributions to clinical research [3][7][8] - Sebastian Wolf, M.D., Ph.D. is a distinguished expert in retina and imaging, with a strong background in clinical and scientific research, particularly in diabetic macular edema [4][10][11] Clinical Pipeline - Oculis' pipeline includes three core product candidates: OCS-01 for diabetic macular edema, Privosegtor (OCS-05) for acute optic neuritis, and Licaminlimab (OCS-02) for dry eye disease, with ongoing late-stage clinical trials [14]

Core Insights - Oculis Holding AG reported strong progress in its clinical pipeline, focusing on unmet medical needs in ophthalmology and neuro-ophthalmology, with significant advancements in its key product candidates [2][4][16] Clinical Development - OCS-01 is in pivotal Phase 3 DIAMOND trials, fully enrolled with over 800 patients across 119 global sites, aiming to be the first eye drop treatment for diabetic macular edema (DME), with topline results expected in Q2 2026 [4][5] - Privosegtor (OCS-05) has shown promising Phase 2 ACUITY trial results in acute optic neuritis, indicating significant improvements in visual function and neuroprotective benefits, with plans for a Phase 2/3 trial expected to initiate in 1H 2026 [4][5] - Licaminlimab (OCS-02) is preparing for a genotype-based Phase 2/3 trial in dry eye disease, expected to start in 2H 2025, following positive results from previous studies [4][5] Financial Overview - As of June 30, 2025, Oculis reported cash, cash equivalents, and short-term investments totaling $201.3 million, providing a cash runway into early 2028 [4][6] - Research and development expenses for Q2 2025 were $18.1 million, a decrease from $18.2 million in Q2 2024, primarily due to the timing of completed trials [6][13] - The year-to-date net loss for the first half of 2025 was $67.9 million, compared to $41.5 million for the same period in 2024, driven by advancements in clinical programs and adjustments in warrant liabilities [6][14] Market Potential - DME affects approximately 37 million people globally, representing a market opportunity of around $5 billion, highlighting the significant unmet medical needs for early intervention [5] - The neuroprotective potential of Privosegtor opens opportunities for various neuro-ophthalmology and neurology indications, addressing high unmet needs in these areas [5][16]

Summary of Oculus Conference Call Company Overview - Oculus is a global biopharma company listed on Nasdaq, focusing on innovative ophthalmology and neuro-ophthalmology candidates targeting significant market opportunities [3][4] Core Assets 1. **OCS-01 (OptiReach)**: A high concentration dexamethasone eye drop for diabetic macular edema (DME), currently in phase three with readout expected in 2026 [3][4] 2. **Privelceptor (OCS-05)**: A first-in-class neuroprotective candidate for acute optic neuritis, currently in development [4][13] 3. **Lickamenimab (OCS-02)**: A novel topical anti-TNF candidate for dry eye disease, starting phase two/three trials in the second half of the year [4][28] Market Insights - **Diabetic Macular Edema (DME)**: - Affects 37 million patients globally, expected to grow to over 50 million by 2045 [6] - Current treatments are invasive, leading to low patient compliance; 56% of diagnosed patients are untreated [6][7] - The U.S. addressable patient population for OCS-01 is estimated at 1.3 million, with a market value of approximately $3 billion [12] - **Acute Optic Neuritis (AON)**: - No approved treatments currently exist; estimated 65,000 patients in the U.S. [15] - High unmet need for neuroprotective therapies [16][24] - **Multiple Sclerosis (MS)**: - Affects approximately 2.8 million worldwide, with a market valued above $20 billion [24] - Oculus aims to address relapses and neuroprotection during acute periods [25] - **Dry Eye Disease**: - A large and unsatisfied market; only 13% of patients experience lasting relief after 12 months [30] - Lickamenimab shows five times better efficacy in signs and seven times better in symptoms for patients with the TNF-R1 genotype [31][32] Clinical Trial Results - **OCS-01**: - Achieved 7.6 letter gains in best corrected visual acuity (BCVA) at week 12 [11] - 27.4% of patients had a 15-letter gain by week 12 [11] - Well tolerated with no unexpected adverse events [11] - **Privelceptor**: - Achieved primary safety endpoint and significant improvements in visual function and neuroprotection in the ACQUITY trial [20][21] - 43% improvement in GCIPL thickness and 30% in RNFL thickness at month six [20][21] - **Lickamenimab**: - Demonstrated rapid treatment effects in both signs and symptoms of dry eye disease [31] - Well tolerated with low incidence of adverse events [34] Future Plans - Anticipate top-line results from OCS-01 phase three program in 2026, with NDA filing in the second half of 2026 [41] - Plans to initiate phase two/three trials for AON and dry eye disease in upcoming quarters [41] - Strong balance sheet to support ongoing development activities [41] Conclusion - Oculus is positioned with a robust portfolio of differentiated products addressing significant unmet needs in ophthalmology and neuro-ophthalmology [40] - Upcoming catalysts across multiple assets and indications are expected to drive growth and shareholder value [40][41]

Core Viewpoint - Immunic Inc reported positive data from the phase 2 EMPhASIS trial of vidofludimus calcium for relapsing-remitting multiple sclerosis (RRMS), indicating a low rate of confirmed disability worsening in treated patients, which supports the drug's potential neuroprotective effects [2][4]. Group 1: Trial Results - The EMPhASIS trial demonstrated a significant reduction in inflammatory lesions on MRI, with 30 mg and 45 mg doses showing reductions of 76% and 78% respectively [4]. - The trial also indicated initial signs of neuroprotection, with a reduction in disability progression by more than 50% [4][5]. - A total of 268 patients were randomized, with 254 entering the open-label extension phase, and 182 remaining on active treatment as of January, highlighting the drug's safety and tolerability [3]. Group 2: Importance of Disability Worsening - Confirmed disability worsening (CDW) is a critical concern for MS patients, as it relates to their independence over time, measured by the EDSS disability score [6]. - The data from the EMPhASIS trial suggests that vidofludimus calcium may address the unmet need to slow down disability progression independent of relapse activity [6]. Group 3: Future Development Plans - Based on the EMPhASIS data, Immunic plans to conduct two phase 3 studies (ENSURE studies) in relapsing MS, with 1,122 patients enrolled, expected to read out by the end of next year [7]. - The studies will also assess the long-term neuroprotective effects as a secondary endpoint, which is crucial for the drug's positioning [8]. - The CALLIPER phase 2 study confirmed a 24% reduction in overall CDW and a 32% reduction in the primary progressive MS subgroup for patients treated with 45 mg, reinforcing the drug's potential efficacy [10].

Core Insights - Masitinib demonstrates neuroprotective effects by lowering serum neurofilament light chain (NfL), a key biomarker for neurodegenerative disorders such as multiple sclerosis, amyotrophic lateral sclerosis, and Alzheimer's disease [1][4][6] Group 1: Research Findings - The study published in PLOS One shows that masitinib can significantly reduce serum NfL levels, indicating its potential neuroprotective effects [1][3] - At Day 8, masitinib treatment reduced NfL levels by 43% at a dosage of 50 mg/kg/day and by 60% at 100 mg/kg/day, demonstrating a dose-dependent response [5][11] - Absolute serum NfL concentrations were approximately 25% lower in both masitinib treatment groups compared to the EAE control group at Day 8, with further reductions observed at Day 15 [5][6] Group 2: Mechanism of Action - Masitinib targets the innate neuroimmune system, specifically mast cells and microglia, which are implicated in the pathophysiology of neurodegenerative diseases [4][7] - The drug has shown clinical benefits in previous trials for progressive multiple sclerosis, ALS, and mild-to-moderate Alzheimer's disease, reinforcing its therapeutic promise [4][6] Group 3: Functional Performance - Masitinib treatment improved grip strength in EAE mouse models, with treated mice recovering to baseline levels by Day 15, indicating a protective effect on motor function [11] - Both treatment groups exhibited significantly less relative deterioration in grip strength compared to the EAE control group (p < 0.001) [11]

Core Insights - Oculis Holding AG reported significant advancements in its clinical portfolio, including the completion of patient randomization in Phase 3 trials and the initiation of a genotype-based development program in ophthalmology [2][5][6] - The company is well-positioned for future growth with a strengthened financial position and several upcoming value inflection points [2][5] Clinical Developments - OCS-01: Enrollment in Phase 3 DIAMOND trials for diabetic macular edema (DME) has been completed with over 800 patients, with topline results expected in Q2 2026 [5][10] - Licaminlimab (OCS-02): A genotype-based development plan for dry eye disease (DED) is aligned with FDA, with the first registrational trial anticipated in 2H 2025 [5][10] - Privosegtor (OCS-05): Positive results from the ACUITY trial indicate neuroprotective effects, leading to plans for a global registration program in acute optic neuritis and potential expansion into other neuro-ophthalmology indications [5][6][10] Financial Overview - As of March 31, 2025, Oculis reported cash, cash equivalents, and short-term investments totaling $206.3 million, reflecting a significant increase from $109.0 million as of December 31, 2024, due to a $100.0 million financing [5][10] - Research and development expenses for Q1 2025 were $16.4 million, up from $12.4 million in Q1 2024, primarily due to costs associated with active clinical trials [10][14] - The net loss for Q1 2025 was $36.9 million, compared to $18.4 million in the same period in 2024, driven by advancements in clinical development and increased general and administrative expenses [10][14]

Core Insights - Oculis Holding AG reported significant advancements in its clinical portfolio, including the completion of patient randomization in Phase 3 trials and the initiation of a genotype-based development program in ophthalmology [2][5][6] - The company is well-positioned for future growth with a strengthened financial position and several upcoming value inflection points [2][5] Clinical Developments - Oculis completed randomization of over 800 patients in the Phase 3 DIAMOND-1 and DIAMOND-2 trials for OCS-01, with topline results expected in Q2 2026 [5][7] - Licaminlimab (OCS-02) is set to initiate its first registrational trial in the second half of 2025, focusing on a personalized medicine approach for dry eye disease [5][12] - Privosegtor (OCS-05) demonstrated promising neuroprotective effects in the ACUITY trial for acute optic neuritis, with plans for a global registration program [5][6][12] Financial Overview - As of March 31, 2025, Oculis reported cash, cash equivalents, and short-term investments totaling $206.3 million, bolstered by a $100 million financing in February 2025 [5][12] - Research and development expenses for Q1 2025 were $16.4 million, an increase from $12.4 million in Q1 2024, primarily due to active clinical trials [12][16] - The net loss for Q1 2025 was $36.9 million, compared to $18.4 million in the same period in 2024, driven by clinical development advancements and increased general and administrative expenses [12][16] Market Opportunity - Diabetic macular edema (DME) currently affects approximately 37 million people globally, representing a market opportunity of around $5 billion [6]